EP3685781A1 - Dispositif de coagulation de tissu - Google Patents
Dispositif de coagulation de tissu Download PDFInfo
- Publication number
- EP3685781A1 EP3685781A1 EP19153586.3A EP19153586A EP3685781A1 EP 3685781 A1 EP3685781 A1 EP 3685781A1 EP 19153586 A EP19153586 A EP 19153586A EP 3685781 A1 EP3685781 A1 EP 3685781A1
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- European Patent Office
- Prior art keywords
- measuring device
- tissue
- optical
- light
- probe
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Definitions
- the invention relates to a device for the treatment of biological tissue.
- Instruments are known in particular for coagulation and ablation which act on the tissue with electrical energy.
- the WO 2012/099974 A2 an instrument that uses electromagnetic energy, for example in the form of high-frequency current and voltage and an argon plasma for coagulation.
- the document also refers to one or more sensors, which can be used, for example, to record the power of the energy supplied, the depth of action, the tissue temperature or other physical parameters, such as a color.
- Electromyographic sensors for recording the electromyography of the muscularis mucosa, a calorimetric sensor, a serum level sensor and an imaging sensor are also mentioned.
- the US 2014/0309632 A1 describes a device with an instrument for tissue ablation by means of RF energy, a corresponding measuring and monitoring system being provided for monitoring the progress of the ablation. This system is set up to record the state of the tissue, which can be done by electrical measurement on the treated tissue. Intravascular ultrasound measurement, optical coherence tomography, optical coherence reflectometry or angiography are also mentioned as measurement options.
- the US 5,321,501 describes an optical imaging of biological tissue using an interference optical sensor with which a tissue surface can be scanned.
- the probe can be an endoscope or angioscope and can be used to scan lumens.
- Several optical paths are provided for parallel scanning.
- the focus point can be moved to enlarge the focus.
- This probe system uses optical coherence tomography as the measurement method and can use it to perform a linear, flat or depth-graded scanning on a tissue surface. Such scans are referred to as A-Scan, B-Scan or C-Scan. In at least one embodiment, this probe can also be designed as an HF ablation probe.
- the US 9,060,750 B2 describes a system with an instrument that acts on a tissue by argon-plasma coagulation.
- the presence of certain chemical substances is inferred by means of optical emission spectroscopy, in which the light captured is examined.
- the US 7,720,532 B2 describes an integrated instrument that can be used as a versatile measuring instrument. It contains an ultrasound sensor comprising a plurality of ultrasound transducers and an electrical sensor with a central electrode and a ring-shaped electrode arranged radially around it, which are arranged together with the ultrasound transducers on the distal end face of the instrument.
- a plasma probe which can contain one or more optical sensors which are provided for monitoring the ablation process.
- the optical sensors can be connected to spectrometers which analyze the light captured and control the ablation process on the basis thereof.
- the device according to the invention can be used, for example, for tissue coagulation.
- a probe body belonging to the device has at least one electrode which can be supplied with an electrical voltage, preferably a high-frequency modulated or unmodulated voltage U HF .
- An electrical current then emanates from the electrode and flows through a plasma and over the biological tissue to be treated. The tissue is changed, in particular coagulated and / or removed.
- the probe body is preferably assigned at least one light guide device which is connected to a measuring device.
- the measuring device is set up as an optical distance measuring device, as a temperature measuring device or as a tissue type determination device. You can also perform two or all of these functions and, if desired, other functions.
- the measuring device is preferably designed as an interferometric distance measuring device that works with multicolored light and enables absolute distance determination. Short-coherent light with a coherence length that is less than the target distance of the probe from the tissue, in particular white light, can be used as light. Long-coherent light with a coherence length that is greater than the desired distance of the probe from the tissue can also be used as light.
- the light-guiding device has a light-receiving window that defines an observation area. This observation area overlaps at least partially with the plasma beam or spark emanating from the probe body.
- the light receiving window can be formed on a GRIN lens or a lens array, which preferably forms a plurality of optical axes and / or a plurality of focal points.
- the optical axes make an acute angle in pairs, i.e. an angle of at most 90 °. They can also be oriented parallel to one another.
- the GRIN lens or the lens array is preferably connected to a monofilament light guide device and this in turn is connected to an optical measuring device.
- the optical measuring device is used for the distance measurement, light can be delivered to the (all) optical axes and focal points via the light guide, and light which is scattered back from them is delivered to the measuring device via the light guide device. This receives the light scattered back from the different points of impact of the light of the different optical axes and brings it to interference with the light from the light source.
- the distances between the tissue and the probe on the individual optical axes can be determined from the interference pattern obtained. Even if the determined distances cannot be individually assigned to individual focal points or optical axes, the measuring device can nevertheless be set up to determine at least the smallest measured distance (minimum distance) or also another desired size, such as, for example, the mean or the largest distance.
- the distance measuring device is preferably an interferometric distance measuring device.
- This uses a light source with sufficient coherence length, at least one beam splitter, a light receiver, light guide and a lens.
- the lens can be a GRIN lens;
- the beam splitter can be a fiber coupler;
- the light guides can be optical fibers;
- the light receiver can be a photodiode or a photodiode array, for example in the form of a camera chip.
- That of the light guides and the at least one beam splitter Fixed light path can contain a measuring path and a reference path.
- the reference path and the measuring path can include the same optical elements, in particular the lens, which is preferably designed as a GRIN lens, and the part of the light path (for example the light guide) leading from the beam splitter to the lens.
- the end surface of the lens (eg the GRIN lens) facing the tissue can serve as a reference mirror.
- the device can be designed in such a way that the operation of the probe, in particular the activation of the electrode and a plasma beam possibly emanating from it, is made dependent on the observance of certain distances, in particular on the non-shortfall of the minimum distance. Because the different optical axes of the GRIN lens or the lens arrangement meet a tissue to be treated at different points, it can thus be ensured by means of several points of impact that the biological tissue does not come too close to the probe at any point.
- the probe according to the invention can be used in particular in a surgical robot.
- the distance measuring device makes this considerably easier.
- the distance between the probe and the tissue can be set much more easily using the distance measurement than using a camera image. This enables remote control of the probe or semi-automatic or fully automatic probe control.
- the probe can have one or more electrodes.
- the probe can be combined with another probe of a similar design or of identical construction to form a double probe.
- the light-guiding device can be provided in the probe body, on the probe body or also on a holder which, for example, accommodates one or more probe bodies. According to this principle, different probe configurations can be created, which are adapted to different uses or locations.
- the light guiding device is at the same time set up to illuminate the measuring location and also to return the light backscattered from the measuring location to the measuring device.
- the measuring device is preferably designed such that it is activated during breaks in which no light emits from the electrode and in particular from the spark or plasma emanating from the electrode. If, for example, pulsed RF voltage U HF is applied to the electrode, the interferometric measuring device is preferably active in the pulse pauses of the RF voltage U HF .
- the measuring device can also be used as a pyrometric temperature measuring device. In this case, it is set up to record the light emanating from the treated tissue, in particular infrared light, and to determine the temperature of the tissue on the basis of its spectral composition. In this case, the measuring device is preferably in turn aligned to be activated during pulse pauses of a pulsed HF voltage U HF with which the electrode is applied.
- the measuring device can also be a combined measuring device which performs both an interferometric distance determination and a pyrometric temperature measurement.
- the measuring device can additionally or exclusively be set up to determine the tissue type detected by the plasma or spark by means of optical emission spectroscopy.
- the measuring device is preferably set up to receive and analyze light during the pulses of the pulsed treatment voltage (HF voltage U HF ).
- the analysis of the light is preferably a spectral analysis. in the context of which the light emanating from the spark or plasma is subjected to a spectral examination.
- the measured spectra can be compared with reference spectra of certain tissue types to differentiate between tissues.
- the spectral lines of chemical elements typical of certain tissue layers can also serve as an indicator for tissue layers, for example the spectral lines of magnesium or calcium.
- optical emission spectroscopy ES the intensity of the light signal is strongly dependent on the distance.
- the optical measuring device is set up to calculate the measured distance with the light signal, for example to convert it to the distance with which the comparison spectrum was recorded, the disturbing influence of changing distances during treatment disappears. It is therefore expedient if the optical measuring device is designed such that it uses both the spectrum and the distance to determine the tissue type.
- the measuring device can also be set up to be permanently active in order to determine the distance of the probe from the tissue and / or the temperature of the tissue during the pulse pauses and to determine the tissue composition during the pulses.
- the invention also includes a method for tissue ablation in which the ablation progress and / or the distance of the probe body from the surface of a biological tissue and / or the tissue type are determined by means of the optical measuring device.
- the method is particularly suitable for mucosal ablation.
- layer-specific emission spectra ES
- the penetration of the ablating plasma into the submucosal layer can be recorded and displayed by an increase in at least one ES signal from magnesium compared to the mucosal layer.
- the penetration of the ablating plasma into the submucosal layer can also be detected and displayed by an increase relative to the mucosal layer of at least one ES signal from calcium.
- a coincidence of the increase in the ES signal from magnesium with an increase in the ES signal from calcium or another marker can be used as an indicator of the penetration of the plasma into the submucosa.
- the penetration of the ablating plasma into the muscularis extern can be detected and displayed by an increase relative to the mucosal layer of at least one ES signal from magnesium
- the penetration of the ablating plasma into the muscularis propria (muscle layer) can also be detected and displayed by an increase relative to the mucosal layer of at least one ES signal from calcium or another marker.
- FIG. 1 A device 10 is illustrated which can be used for tissue coagulation, for tissue ablation or for other tissue treatment.
- the device 10 includes a probe 11 and a supply device 12 feeding the probe 11. This can be formed by one or more devices and is shown in FIG Figure 1 represented simply as a block.
- the subsequent use of the term “device 12” also encompasses a number of devices that are combined in operative terms.
- the probe 11 can be an endoscopic probe or an instrument for laparoscopic use or for open surgical use. Unless this is excluded in principle, the structural and functional details explained below apply to each of these types.
- the probe 11 is connected via one or more lines 13 and one or more plugs 14 to the device 12, which provides the operating power and the media for the operation of the probe 11.
- the probe 11 has a rigid or flexible probe body 15, in or on which an electrode 16 is held.
- the electrode 16 is arranged in a fluid channel 17 which extends longitudinally through the probe body 15 and leads to the plug 14 and through which extends an electrical line which supplies the electrode 16 with electrical power.
- the fluid channel 17 preferably opens at an end face 18 of the distal end of the probe body 15.
- the probe body 15 can also be provided with a light-guiding device 19 which extends from the distal end of the probe body 15 to the Plug 14 extends.
- the light guide device 19 At the distal end of the light guide device 19 there is an opening 20 through which light can enter and exit and can thus be emitted from the light guide device 19 to a treatment site and received by the latter.
- the fluid channel 17 and the light-guiding device 19 preferably run in the same direction through the probe body 15.
- Figure 4 illustrates a further modification in which two probes 11a, 11b are combined to form a twin probe.
- the two probes 11a, 11b can be constructed identically or differently. They can be designed with or without an optical light-guiding device and with or without light entry or exit windows.
- a light guide device 19 is attached to a holder 21, which connects the two probes 11a, 11b to one another.
- the probe variants presented by Figures 2 to 4 are examples that can be combined.
- the probes can be used Figure 2 and 3 with a holder after Figure 4 can be combined into a twin probe.
- One of the probes can also be used Figure 2 or 3 with one of the probes 15a or 15b in the holder 21 Figure 4 can be combined into a twin probe. All of these arrangements have in common that they contain at least one electrode 16, at least one light guide 19 and at least one fluid channel 17. Correspondingly there are at least one electrical generator 22 in the device 12, which is connected via the plug 14 and the line 13 is connected to the electrode 16, a gas source 23, which is connected via the connector 14 and the line 13 to the fluid channel 17, and a measuring device 24 is provided, which via the connector 14 and the line 13 to the light guide device 19 is connected.
- the generator 22 is preferably a controllable high-voltage generator controlled by a control circuit (not shown further). It is preferably set up to emit a high-frequency alternating voltage U HF, preferably at a frequency of well above 100 kHz, for example 350 kHz. It is also set up to modulate the high-frequency alternating voltage U HF , for example with a square wave, so that there is a pulsed voltage output with pulses 25 and pauses 26, as is the case Figure 10 for the high-frequency AC voltage U HF is illustrated.
- the controller or generator 22 can be set up to vary the ratio of the time periods of the pulses 25 and pauses 26 according to predetermined settings, predetermined modes or else according to control signals.
- the gas source 23 can also be connected to the control device (not illustrated further) in order to selectively enable or block a gas flow and / or to set the flow rate.
- the gas flow can be blocked and released and / or the flow rate can be set according to user settings, according to selected operating modes and / or using control signals.
- the measuring device 24 is an optical measuring device which is used as an optical distance measuring device and / or as a pyrometric temperature measuring device and / or as a measuring device for determining the type of tissue, preferably on the basis of optical emission spectroscopy. If the opotic measuring device 24 determines several variables at the same time, for example distance and temperature or distance and tissue type, better accuracies for the temperature or the tissue type can be achieved than without taking the distance into account.
- a lens arrangement 27 serving as an objective can be arranged, which comprises, for example, a GRIN lens 28.
- This can be designed such that it splits or splits the beam path into a plurality of optical axes 29, 30, 31.
- a central optical axis 31 can be identical to the optical axis 31 of the light guide device 19.
- Further optical axes 29, 30 (for example 6 in number) can be arranged on a cone jacket around the optical axis 31.
- the optical axes 29, 30, 31 can form an angle with one another in pairs, preferably an angle of at most 90 °, ie an acute angle.
- Figure 6 illustrated for lens assembly 27 of FIG Figure 5 in accordance with the resulting light bundles, which can be focused and thus define focal points 32, 33, 34. These are preferably arranged on a common surface 35, for example a sphere, a cylindrical surface or a plane. In addition, they are preferably at a distance from the GRIN lens 28 that approximately corresponds to the distance the GRIN lens 28 is from a biological tissue 36 when the probe 15 is used, as shown in FIG Figure 7 is indicated schematically.
- FIG. 7 illustrates schematically and mainly limited to the optical components the structure of the measuring device 24, which is designed as an interferometric measuring device for distance control or distance measurement.
- the measuring device includes a light source 37, for example in the form of a white light source or a tunable laser. This is connected to the light guide device 19 via a fiber coupler 38, which serves as a beam splitter.
- the fiber coupler 38 is also connected to a light receiver 39 which receives both parts of the light emitted by the light source 37 and parts of the light reflected by the surface of the fabric 36. If necessary, a reference light path terminated with a reflector can be coupled to the beam path via a further fiber coupler 38 '.
- the light path in the portion of the light guide 19 from the steel splitter 38 to the GRIN lens to the end face thereof serves as a reference light path.
- the end surface of the GRIN lens (or another lens) reflects part of the light and thus forms the reference mirror.
- a separate reference light path can be omitted.
- the interferometer can be designed to work both with short-coherent light (white light interferometer) and with light of a longer coherence length.
- a tunable is used for measuring the distance in the measuring device 24
- Light source 37 used which can emit light of variable wavelength.
- the individual spectral lines of the light spectrum are received one after the other when tuning the light source 37.
- Figure 8 generated by spectral decomposition of the light supplied by the fiber coupler 38 to the light receiver 39 and registered and generated by a corresponding plurality of light receiving elements.
- the measuring device 24 can be set up to determine the smallest of the distance values d 1 , d 2 , d 3 and to make this available to the control of the device 12 for further processing.
- the controller can control the generator 22, for example switch it on and off, or influence its performance and / or its duty cycle (pulse, pause ratio).
- the controller can also use this smallest distance value d 1 to switch the gas source 23 on or off or to initiate increased or reduced gas delivery.
- the interference optical measuring device 24 described so far is active during the pauses 26 of the pulsed RF voltage U HF applied to the electrode 16, as shown in FIG Figure 10 is illustrated in the top diagram for the first optical measurement O 1 .
- the generator 22, as is Figure 9 schematically represents, communicate directly or through the control of the device 12 with the optical measuring device 24 so that the measuring device 24 works synchronized to the generator 22.
- the measuring device 24 it carries out a tissue surface temperature measurement, in that it also detects the radiation emanating from the surface of the tissue 36, in particular infrared radiation, during the breaks 26 and uses this to carry out pyrometric temperature detection.
- the optical measuring device 24 is used as part of a tissue determination or classification device which determines the type of tissue hit by the spark or the plasma by optical emission spectroscopy.
- This measurement is in Figure 10 illustrated in the lower diagram O 2 .
- the measuring device 24 for performing this measurement is preferably active during the pulses 25.
- the light source 37 is inactive or is omitted entirely.
- the fiber coupler 38 (and, if present, the fiber coupler 38 ') can also be omitted.
- the light receiver 39 receives the light emanating from the spark or plasma and in turn determines the spectrum thereof in accordance with the illustration in FIG Figure 8 Left. The acquired spectrum can be compared with a reference spectrum in order to determine the tissue type conclude.
- the typical spectral lines of magnesium and / or calcium can also be determined, from their presence and size let, with which of the layers the plasma is induced, ie which layer is unloaded.
- the measuring device 24 can accordingly generate one or more control signals which identify the smallest distance of the probe from the tissue and / or the tissue temperature and / or the tissue type.
- the control device of the device 12 can be set up to control the generator 22 and / or the gas source 23 in accordance with this signal.
- the control device can stop the generator 22 as soon as the minimum distance between the probe and the tissue is undershot.
- the control device can deactivate the gas source 23.
- the probe can be guided completely, or at least with regard to its distance to the tissue, in that a distance control device automatically sets the desired treatment distance between the probe and the tissue on the basis of the distance measurement.
- the measured distance it is also possible to display the measured distance to an operator during operation of the probe so that the operator is not solely dependent on a camera image when the probe is being guided.
- the control device can deactivate the generator 22 and / or the gas source 23 as soon as the measuring device 24 uses the optical emission spectrum of the plasma or the spark to determine the influence of a tissue type that is not to be influenced.
- the interaction of the measuring device 24 with, for example, the generator 22 is shown in FIG Figure 9 schematically illustrated. It can go beyond switching the generator 22 and / or the gas source 23 on and off.
- the pulse / pause ratio of the generator 22 and / or the size of the gas flow of the gas source 23 can be set or regulated using the control signal.
- the pulse / pause ratio of the HF voltage U HF emitted by the HF generator 24 can be reduced if the tissue temperature measured by the measuring device exceeds a limit value.
- the gas flow from the gas source 23 can be increased or decreased. In this way, an automatic adaptation of the operation of the generator 22 and / or the gas source 23 to the respective temporary operating states of the probe 11 can be achieved.
- a probe 16 which can belong to a medical instrument, can be provided with a high-voltage electrode 16 and a light guide device 19, which is connected to a measuring device 24.
- This can be designed as an optical distance measuring device and / or as a temperature measuring device and at least optionally also as a device for determining the treated tissue type by means of optical emission spectroscopy.
- the optical measuring device serves as a distance measuring device, it is particularly preferably designed as an interference-optical measuring device which is set up to measure the distance of the To determine the probe or the light guide from several points of the treated tissue simultaneously.
- the device 10 can be used for tissue coagulation and / or for tissue ablation. It comprises at least one electrode 16, which is used to generate a spark or a plasma beam and can be connected to an electrical source 20 for this purpose.
- a probe 24 is assigned to the probe 11, which emits and / or records light in the vicinity of the electrode 16 and determines the distance of the probe 11 from the tissue 36 and / or the tissue temperature and / or the composition of the affected tissue 36.
- the measuring device 24 is preferably operated synchronized with pulses or pauses in the pulse-pause-modulated HF voltage U HF of the electrode 16, in order to simultaneously carry out the desired measurements during operation of the instrument 11 and to regulate the operation of the instrument 11 on the basis of the measurement results obtained can.
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Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL19153586T PL3685781T3 (pl) | 2019-01-24 | 2019-01-24 | Przyrząd do koagulacji tkanek |
EP19153586.3A EP3685781B8 (fr) | 2019-01-24 | 2019-01-24 | Dispositif de coagulation de tissu |
BR102020000409-3A BR102020000409B1 (pt) | 2019-01-24 | 2020-01-08 | Dispositivo para a coagulação de tecidos |
KR1020200006665A KR20200092880A (ko) | 2019-01-24 | 2020-01-17 | 조직 응고를 위한 디바이스 |
RU2020101946A RU2813711C2 (ru) | 2019-01-24 | 2020-01-17 | Устройство для коагуляции биологической ткани |
JP2020007010A JP7408407B2 (ja) | 2019-01-24 | 2020-01-20 | 組織凝固用の装置 |
US16/748,139 US11730530B2 (en) | 2019-01-24 | 2020-01-21 | Device for tissue coagulation |
CN202010074139.6A CN111467027B (zh) | 2019-01-24 | 2020-01-22 | 用于组织凝固的装置 |
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EP19153586.3A EP3685781B8 (fr) | 2019-01-24 | 2019-01-24 | Dispositif de coagulation de tissu |
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EP3685781A1 true EP3685781A1 (fr) | 2020-07-29 |
EP3685781B1 EP3685781B1 (fr) | 2022-04-13 |
EP3685781B8 EP3685781B8 (fr) | 2022-06-29 |
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EP19153586.3A Active EP3685781B8 (fr) | 2019-01-24 | 2019-01-24 | Dispositif de coagulation de tissu |
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US (1) | US11730530B2 (fr) |
EP (1) | EP3685781B8 (fr) |
JP (1) | JP7408407B2 (fr) |
KR (1) | KR20200092880A (fr) |
CN (1) | CN111467027B (fr) |
PL (1) | PL3685781T3 (fr) |
Cited By (1)
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---|---|---|---|---|
EP3964822A1 (fr) * | 2020-09-03 | 2022-03-09 | Erbe Elektromedizin GmbH | Dispositif et procédé d'analyse tissulaire |
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US20240058062A1 (en) * | 2020-12-15 | 2024-02-22 | Ne Scientific, Llc | System and method for ablation treatment of tissue with interactive guidance |
EP4183357A1 (fr) * | 2021-11-18 | 2023-05-24 | Erbe Elektromedizin GmbH | Instrument médical |
CN114886545B (zh) * | 2022-05-07 | 2023-11-28 | 宇寿医疗科技(无锡)有限公司 | 一种同步双极性短脉冲肿瘤消融方法与装置 |
CN114886546B (zh) * | 2022-05-09 | 2023-11-28 | 宇寿医疗科技(无锡)有限公司 | 一种同步双极性短脉冲肿瘤消融方法与*** |
EP4342403A1 (fr) * | 2022-09-22 | 2024-03-27 | Erbe Elektromedizin GmbH | Procédé de détermination d'un état d'un guide d'ondes optique d'un instrument électrochirurgical et système comprenant un instrument électrochirurgical |
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Also Published As
Publication number | Publication date |
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US11730530B2 (en) | 2023-08-22 |
CN111467027A (zh) | 2020-07-31 |
BR102020000409A8 (pt) | 2023-03-21 |
JP7408407B2 (ja) | 2024-01-05 |
RU2020101946A (ru) | 2021-07-19 |
KR20200092880A (ko) | 2020-08-04 |
EP3685781B8 (fr) | 2022-06-29 |
US20200237421A1 (en) | 2020-07-30 |
CN111467027B (zh) | 2023-07-14 |
PL3685781T3 (pl) | 2022-07-11 |
JP2020121116A (ja) | 2020-08-13 |
EP3685781B1 (fr) | 2022-04-13 |
BR102020000409A2 (pt) | 2020-08-04 |
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